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FDA clears NxStage TPE Cartridge

NxStage Medical, a manufacturer of dialysis products, has received the Food and Drug Administration clearance to market its Therapeutic Plasma Exchange (TPE) cartridge for use with the NxStage System One in a clinical environment.

TPE, also known as plasmapheresis, is an extracorporeal blood purification technique which replaces a part of patient’s plasma with fresh frozen plasma or a solution containing albumin.

TPE may be performed to treat immunological, hematological, and neurological disorders.

NxStage North American operations president Joseph Turk said that they are delighted to introduce this exciting new product to their customers, as therapeutic plasma exchange capability adds to the advantages that the NxStage System One offers.

"By leveraging the simplicity, ease of use and flexibility of the NxStage System One, we are further enabling staff to customize therapy in order to better meet the clinical needs of their patients," Turk said.